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NCT00317226 · ClinicalTrials.gov registry record · Phase 3

Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

A Phase 3 study, sponsored by American Regent.

Completed
Registry status
Phase 3
Development phase
145
Enrollment target

NCT00317226 is a Phase 3 study that has completed, run by American Regent. The registered enrollment target is 145 participants.

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The verdict

NCT00317226, a Phase 3 study, has completed, sponsored by American Regent.

COMPLETED
Registry status
Phase 3
Development phase
145 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

Interventions

  • DRUG Ferric Carboxymaltose (FCM)

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2005-06
Est. Completion 2007-09
Phase Phase 3

Sponsor

American Regent

34 total trials

What the Registry Record Tells You About NCT00317226

The ClinicalTrials.gov registry entry for NCT00317226 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Ferric Carboxymaltose (FCM) is the first listed.

NCT00317226 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00317226 about?

NCT00317226 is a clinical study titled "Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease". The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT0031723...

What is the current status of trial NCT00317226?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2005-06. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00317226?

The interventions under investigation include: Ferric Carboxymaltose (FCM) (DRUG).

Who is sponsoring clinical trial NCT00317226?

This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.